Adjustable valve having a radially compressible sealing body

ABSTRACT

An adjustable surgical valve has a sealing body with an axial passage extending through it, a toroidal body axially aligned with the sealing body, and a device that selectively changes the relative axial positions of the sealing body and the toroidal body. The sealing body and the toroidal body have mating surfaces which radially compress the axial passage of the sealing body when the relative axial positions of the sealing body and the toroidal body are changed. This causes the axial passage to seal with an instrument inserted into it, or to seal with itself if no instrument is inserted. Alternatively, or additionally, the sealing body may include a braided sleeve coaxial with the axial passage and extending from the sealing body, and a device that selectively changes the relative axial positions of the sealing body and the extended part of the braided sleeve to elongate the braided sleeve. This causes the braided sleeve to contract radially, which compresses the axial passage of the sealing body radially. The sealing body is made of an elastomeric foam or an encapsulated gel.

BACKGROUND OF THE INVENTION

In cardiac, vascular, urology, laparoscopic cholecystectomy and othermedical procedures using catheters, there has been an increasing needfor large-diameter valves. These procedures use catheters having a widerange of diameters. These procedures may also use multiple catheters.

Current surgical valves fall into two basic categories, passive andactive. A passive valve relies on the deformation of a resilient part bythe catheter to form the required fluid-tight seal with the catheter. Arecent example of a passive valve is described in U.S. Pat. No.4,909,798, in which the valve has a longitudinally extended valvehousing with a first opening and a central longitudinal passagecommunicating with an opposite second opening. A one-piece seal locatedin the longitudinally extended valve housing has a sealing neck having arelatively small opening that communicates with a sealing chamber. Onthe opposite side of the sealing chamber are sealing exit lips that arereadily expansible to a diameter less than that of the valve housingwhen a catheter is inserted. This surgical valve does not accommodate awide range of catheter diameters. A seal that exerts enough lateralpressure to seal around a small-diameter catheter applies too muchfriction when sealing a large-diameter catheter. Moreover, the lip-typeseals tend not to seal uniformly around all of the circumference of thecatheter.

An active surgical valve includes a mechanism that moves a seal intocontact with the catheter when the catheter is in place in the valve. Acommon feature of such valves is a tube of a flexible material throughwhich the catheter is inserted. A mechanism moves the flexible materialinto contact with the catheter.

Some valves, such as the valves shown in U.S. Pat. Nos. 3,977,400 and4,243,034, use a simple vise-like arrangement with opposing jaws tobring the flexible material into contact with the catheter. With such anarrangement, the contact pressure between the flexible material and thecatheter is very non-uniform around the circumference of the catheter. Adevelopment of this arrangement uses two pairs of opposing jawsperpendicular to one another to produce a more uniform contact pressure.

U.S. Pat. No. 3,970,089 describes a tube of a flexible materialsurrounded by an annular vessel into which a fluid can be pumped toapply pressure to the outer wall of the tube, and hence to move theinner wall of the tube into contact with the catheter. This arrangementprovides a uniform contact pressure between the tube and the catheter,but the range of catheters that can be sealed without the wall of thetube buckling, and providing a leakage path, is limited.

U.S. Pat. No. 4,580,573 shows an arrangement in which a flexible tubehas a rigid tube connected to each end. The catheter passes through therigid tubes and the flexible tube. By rotating one of the rigid tubesaxially relative to the other a twist is imposed on the flexible tube,which reduces the internal diameter of the flexible tube such that theinner wall of the flexible tube forms a seal with the catheter.

Current surgical valves have a tendency to leak, especially if multiplecatheters are used. Additionally, current surgical valves can only beused with catheters having a relatively narrow range of diameters.Current large diameter surgical valves do not close completely andrequire that the catheter be left in place to maintain a seal. Currentsurgical valves require constant manipulation to maintain a seal aroundthe catheter without excessive friction.

OBJECTS AND SUMMARY OF THE INVENTION

An adjustable surgical valve according to a first aspect of theinvention comprises a sealing body that has an axial passage extendingthrough it, a toroidal body that is axially aligned with the sealingbody, and a device that selectively changes the relative axial positionsof the sealing body and the toroidal body. The sealing body and thetoroidal body have mating surfaces which radially compress the axialpassage of the sealing body when the relative axial positions of thesealing body and the toroidal body are changed. Radially compressing theaxial passage causes the axial passage to seal with an instrumentinserted into it; or to seal with itself if no instrument is insertedinto the axial passage.

An adjustable surgical valve according to a second aspect of theinvention comprises a sealing body that has an axial passage extendingthrough it. The sealing body includes a braided sleeve that is coaxialwith the axial passage and that extends from the sealing body. The valvealso comprises a device that selectively changes the relative axialpositions of the sealing body and part of the braided sleeve remote fromthe sealing body. Changing the relative axial positions of the sealingbody and the remote part of the braided sleeve elongates the braidedsleeve, which causes the braided sleeve to contract radially, andcompresses the axial passage of the sealing body radially. Radiallycompressing the axial passage causes the axial passage to seal with aninstrument inserted into it; or to seal with itself if no instrument isinserted into the axial passage.

In a first practical embodiment of an adjustable surgical valveaccording to the invention, the mating surface of the sealing body isits outer surface and the mating surface of the toroidal body is itsinner surface. In the plane perpendicular to the axis defined by theaxial passage in the sealing body ("the axis"), the distance of theouter surface of the sealing body from the axis is substantiallyconstant. In the same plane, the distance of inner surface of thetoroidal body from the axis decreases along the axis from greater thanthe distance of the outer surface of the sealing body from the axis toless than the distance of the outer surface of the sealing body from theaxis. The sealing body is located in a substantially fixed axialposition by a braided sleeve, and the means for selectively changing therelative axial positions of the sealing body and the toroidal body movesthe toroidal body axially relative to the sealing body.

When the valve is in its open (non-sealing) position, the matingsurfaces of the sealing body and the toroidal body are substantiallydisengaged. The valve is closed by moving the toroidal body axially intoengagement with the sealing body such that, as the toroidal body ismoved, the distance from the axis of the inner surface of the toroidalbody engaged with a given point on the sealing body progressivelydecreases. The rigid inner surface of the toroidal body thus deforms thecompliant outer surface of the sealing body radially towards the axis.The toroidal body additionally elongates the braided sleeve. Theresulting compression of the sealing body compresses the axial passageand forms the required seal.

The valve is opened by moving the toroidal body axially relative to thesealing body in the opposite direction, i.e., such that the distancefrom the axis of the inner surface of the toroidal body engaged with agiven point on the sealing body progressively increases. This reducesthe radial deformation of the outer surface of the sealing body and theelongation of the braided sleeve, which reduces the deformation of theaxial passage, and releases the seal. The means for changing therelative positions of the sealing body and the toroidal body in thefirst practical embodiment of the valve includes a ratchet mechanism.

In a second practical embodiment of an adjustable surgical valveaccording to the invention, the mating surface of the sealing body isits outer surface and the mating surface of the toroidal body is itsinner surface. In the plane perpendicular to the axis, the distance ofthe inner surface of the toroidal body from the axis is substantiallyconstant. In the same plane, the distance of the outer surface of thesealing body increases along the axis, from less than the distance ofthe inner surface of the toroidal body from the axis to greater than thedistance of the inner surface of the toroidal body from the axis. Thesealing body includes a braided sleeve. The toroidal body has a fixedposition and the means for selectively changing the relative axialpositions of the sealing body and the toroidal body moves the sealingbody axially relative to the sealing body.

When the valve is in its open (non-sealing) position, the matingsurfaces of the sealing body and of the toroidal body are substantiallydisengaged. The valve is closed by moving the sealing body axially tobring its outer surface into engagement with the inner surface of thetoroidal body such that, as the sealing body is moved, the distance fromthe axis of the outer surface of the sealing body engaged with a givenpoint on the inner surface of the toroidal body progressively increases.Because the inner surface of the toroidal body is rigid, it deforms theouter surface of the sealing body radially towards the axis. The axialmotion of the sealing body also elongates the braided sleeve. Theresulting compression of the sealing body compresses the axial passageand forms the required seal.

The valve is opened by moving the sealing body axially relative to thetoroidal body in the opposite direction, i.e., such that the distancefrom the axis of the outer surface of the sealing body engaged with agiven point on the inner surface of the toroidal body progressivelydecreases. This reduces the radial compression applied to the sealingbody and releases the seal. The means for changing the relativepositions of the sealing body and the toroidal body in the secondpractical embodiment of the hemostasis valve according to the inventionincludes a mechanism that translates a twisting motion to an axialmotion.

Practical embodiments of an adjustable surgical valve according to theinvention employ both mating surfaces and axial stressing of a braidedsleeve to apply a uniform radial compression to the axial passage in thesealing body.

It is an object of the invention to provide an adjustable surgical valvethat can be adjusted to seal around instruments having a wide range ofdiameters without leaking.

It is a further object of the invention to provide an adjustablesurgical valve that provides a seal that is both liquid-tight andgas-tight.

It is a further object of the invention to provide an adjustablesurgical valve that provides good tactile feedback without leaking.

It is a further object of the invention to provide an adjustablesurgical valve that seals around multiple instruments.

It is a further object of the invention to provide an adjustablesurgical valve that can easily be adjusted using one hand.

It is a further object of the invention to provide an adjustablesurgical valve that, once adjusted to seal around a given instrument,does not require further adjustment to maintain the seal.

It is a further object of the invention to provide an adjustablesurgical valve that is self-sealing when the instrument is withdrawn.

In a first method of manufacturing an adjustable surgical valveaccording to the invention, a sealing body is attached inside the oneend of a braided sleeve, the other end of the braided sleeve is threadedthrough the bore of a toroidal body, and the braided sleeve, toroidalbody, and sealing body are inserted into the bore of a substantiallycylindrical valve body. In a variation on the first method, the sealingbody is attached to the braided sleeve by molding it in place in thebraided sleeve.

In a second method of manufacturing an adjustable surgical valveaccording to the invention, a braided sleeve is inserted into the boreof a collar and the collar is attached to the braided sleeve part-wayalong the length of the braided sleeve. An elastomeric foam sealing bodyis molded along the length of, coaxial with, and surrounding the braidedsleeve, and the sealing body is inserted into a cylindrical valve body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a longitudinal cross sectional view of the sealing mechanismof an adjustable surgical valve according to the first aspect of theinvention in its open (non-sealing) position.

FIG. 1B is a longitudinal cross sectional view of the sealing mechanismof an adjustable surgical valve according to the first aspect of theinvention in its closed (sealing) position.

FIG. 2A is a transverse cross-sectional view of the sealing mechanism ofan adjustable surgical valve according to the first aspect of theinvention sealed around an instrument inserted into the axial passage ofthe valve.

FIG. 2B is a transverse cross-sectional view of the sealing mechanism ofan adjustable surgical valve according to the first aspect of theinvention sealed after the instrument has been withdrawn.

FIG. 3 is a transverse cross-sectional view of the sealing mechanism ofan adjustable surgical valve according to the first aspect of theinvention sealed around two instruments.

FIG. 4A is a perspective view of the sealing mechanism of an adjustablesurgical valve according to the second aspect of the invention in itsopen (non-sealing) position.

FIG. 4B is a perspective view of the sealing mechanism of an adjustablesurgical valve according to the second aspect of the invention in itsclosed (sealing) position.

FIG. 4C is a perspective view of an alternative form of the sealingmechanism of an adjustable surgical valve according to the second aspectof the invention in its open (non-sealing) position.

FIG. 5A is a longitudinal cross sectional view of a more completeembodiment of an adjustable surgical valve according to the secondaspect of the invention in its open (non-sealing) position.

FIG. 5B is a longitudinal cross sectional view of a more completeembodiment of an adjustable surgical valve according to the secondaspect of the invention in its closed (sealing) position.

FIG. 6 is a perspective view of a first practical embodiment of anadjustable surgical valve according to the invention.

FIG. 7 is a longitudinal cross-sectional view of the first practicalembodiment of an adjustable surgical valve according to the invention inits open (non-sealing) position.

FIG. 8 is a longitudinal cross-sectional view of the first practicalembodiment of an adjustable surgical valve according to the invention inits closed (sealing) position sealed around an instrument inserted intothe axial passage of the valve.

FIG. 9 is a longitudinal cross-sectional view of the first practicalembodiment of an adjustable surgical valve according to the invention inits closed (sealing) position with the instrument removed.

FIG. 10 is a perspective view of a second practical embodiment of anadjustable surgical valve according to the invention.

FIG. 11 is a longitudinal cross-sectional view of the second practicalembodiment of an adjustable surgical valve according to the invention inits open (non-sealing) position.

FIG. 12 is a longitudinal cross-sectional view of the second practicalembodiment of an adjustable surgical valve according to the invention inits closed (sealing) position.

DETAILED DESCRIPTION OF THE INVENTION

The basic sealing mechanism of an adjustable surgical valve according toa first aspect of the invention is illustrated in FIGS. 1A and 1B. FIG.1A shows the valve in its open (non-sealing) position. The adjustablesurgical valve 1 has a sealing body 6, a toroidal body 11, and amechanism (not shown) for changing the axial position of at least one ofthe sealing body 6 and the toroidal body 11 relative to the other.

The sealing body has an outer surface 36 that is its mating surface. Thesealing body has an axial passage 16 through which one or moreinstruments, such as the catheter C, can be passed from the proximal end21 of the sealing body to the distal end 26, in the direction indicatedby the arrow 31. Sealed to the distal end 26 of the sealing body is theintroducer sleeve S through which the catheter C passes into the body(not shown). The catheter C is shown throughout as an example of aninstrument that is inserted into the axial passage of the valve. Thevalve can be used with instruments other than catheters, however.

The sealing body 6 is preferably formed of a resilient elastomeric foammaterial that is compliant, but is sufficiently strong in compression toenable a substantially uniform radial deformation of the outer surface36 of the sealing body towards the axis to move the wall of the axialpassage 16 radially towards the axis to contact, and to form a sealwith, the catheter C, or, if no catheter is in the axial passage, tocontact itself and to seal the axial passage. The sealing body 6 mayalternatively be formed of an encapsulated medical silicone gel, such asDow Corning Q7-2147. The preferred encapsulation material is RTV, suchas G.E. 118.

Preferably, the outer surface 36 of the sealing body intersects a planeperpendicular to the axis defined by the axial passage 16 ("the axis")to form a circle, but can form other suitable shapes such as a square, arectangle, a hexagon, an octagon, etc.

The toroidal body 11 is axially aligned with the sealing body 6, and hasa proximal end 41 and a distal end 46. The toroidal body 11 is formed ofa relatively rigid material, such as plastic or metal. The matingsurface of the toroidal body 11 is its inner surface 51. Theintersection of the inner surface 51 of the toroidal body with a planeperpendicular to the axis preferably forms the same shape as the outersurface 36 of the sealing body, i.e., a circle, but can form othersuitable shapes such as a square, a rectangle, a hexagon, an octagon,etc.

In FIG. 1A, the distance from the axis of the outer (mating) surface 36of the sealing body is shown as progressively decreasing from theproximal end 21 of the sealing body to the distal end 26, and thedistance from the axis of the inner (mating) surface 51 of the toroidalbody is also shown as progressively decreasing from the proximal end 41of the toroidal body to the distal end 46. However, if the distance fromthe axis of the outer surface 36 of the sealing body progressivelydecreases between the proximal end 21 and the distal end 26, thedistance from the axis of the inner surface 51 of the toroidal body maybe substantially constant along the axis. Alternatively, if the distancefrom the axis of the inner surface 51 of the toroidal body progressivelydecreases between the proximal end 41 and the distal end 46, thedistance from the axis of the outer surface 36 of the sealing body maybe substantially constant along the axis. In any of the three cases juststated, the distance from the axis of the inner surface 51 at theproximal end 41 of the toroidal body should be less than the distancefrom the axis of the outer surface 36 at the proximal end 21 of thesealing body, and greater than the distance of the outer surface 51 atthe distal end 26 of the sealing body.

The toroidal body 11 can be made considerably shorter in the axialdirection than shown in FIG. 1A. A ring with a square, rectangular,circular, or other suitable cross section in the plane of the axis canbe used for the toroidal body 11. Alternatively, the toroidal body 11can comprise a plurality of substantially spherical or cylindrical beadson a substantially circular axis in the plane perpendicular to the axis.Such an arrangement reduces friction by providing the toroidal body 11with an inner surface that rolls over the outer surface 36 of thesealing body instead of sliding.

FIG. 1A shows the adjustable surgical valve 1 according to the inventionin its open (non-sealing) position. The sealing body 6 and the toroidalbody 11 are axially positioned such that the inner surface 51 of thetoroidal body is disengaged from the outer surface 36 of the sealingbody. The toroidal body 11 thus exerts no radial compression on thesealing body 6, the axial passage 16 in the sealing body is fully open,which allows the catheter C to be freely inserted or withdrawn.

FIG. 1B shows the adjustable surgical valve according to the inventionin its closed (sealing) position. The relative axial positions of thesealing body 6 and the toroidal body 11 have been changed in thedirection shown by the arrow 56 to engage the inner surface 51 of thetoroidal body with the outer surface 36 of the sealing body. This changein the relative axial positions is brought about by a suitable mechanism(not shown) that moves the sealing body relative to the toroidal body,or moves the toroidal body relative to the sealing body, or moves thesealing body and the toroidal body relative to one another. The rigidinner surface 51 of the toroidal body deforms radially towards the axisthe part of the outer surface 36 of the sealing body with which it isengaged. This applies a uniform radial compression to the sealing body.The material of the sealing body transmits the uniform radialcompression applied by the deformation of the outer surface of thesealing body to the part of the axial passage 16 substantially oppositethe deformed outer surface. The uniform radial compression deformssufficiently to bring the wall of the axial passage into contact with,and to seal, the catheter C.

With the relative positions of the sealing body 6 and the toroidal body11 adjusted to bring the wall of the axial passage 16 into sealingcontact with the catheter C, the catheter is sealed by a relativelylarge area of the compliant material of the sealing body. This providesa leak-proof seal using a relatively small radial force between thesealing body and the catheter. The resulting small frictional forcebetween the sealing body and the catheter gives excellent "feel" whenthe catheter is inserted or adjusted. In this adjustment condition, thecatheter can be adjusted or withdrawn without having to adjust therelative positions of the sealing body and the toroidal body. Thisadjustment condition will be called the "minimum friction-no leakage"condition.

Further change in the relative axial positions of the sealing body 6 andthe toroidal body 11 in the direction shown by the arrow 56 increasesthe uniform radial compression on the sealing body. This causes furtherdeformation of the axial passage 16. The axial passage is deformed overmore of its length, and the radial force between the wall of the axialpassage 16 and the instrument, such as the catheter C, is increased.This increases the friction between the sealing body and the catheter C,but further reduces the possibility of leakage. Further change in therelative axial positions of the sealing body and the toroidal body inthe direction shown by the arrow 56 enables the valve to seal with asmaller diameter catheter, or to seal with no catheter.

Using an elastomeric foam or an encapsulated silicone gel to form thesealing body 6 enables the valve to accommodate a large diametercatheter and to seal without leaking when the large diameter catheter iswithdrawn. The sealing body 6 also enables the valve to be self-sealingwhen the catheter is withdrawn. FIGS. 2A and 2B show cross sections ofthe valve in the plane perpendicular to the axis to illustrate theself-sealing action of the valve. In FIG. 2A, the relative axialpositions of the toroidal body 11 and the sealing body 6 have beenadjusted to deform the axial passage 16 such that its wall seals withthe catheter C. FIG. 2B shows the valve after the catheter has beenwithdrawn. When the catheter is withdrawn, the resilience of the sealingbody moves the wall of the axial passage further towards the axis, sothat the wall seals with itself.

With a relatively small diameter catheter, the relative axial positionsof the toroidal body 11 and the sealing body 6 can be adjusted to theminimum friction-no leakage position after the catheter is inserted, andthe valve will be self-sealing without the need to readjust it when thecatheter is withdrawn. In FIG. 2B, which shows the valve after thecatheter has been withdrawn, the diameter of the outer surface 36 is thesame as in FIG. 2A, which indicates that the relative positions of thetoroidal body and the sealing body were not changed when the catheterwas withdrawn.

With a larger diameter catheter, the relative positions of the toroidalbody and the sealing body must be adjusted to produce a radial force onthe axial passage 16 that is greater than the radial force for minimumfriction for the valve to be self-sealing when the catheter iswithdrawn.

Using an elastomeric foam that is also compliant, or an encapsulatedsilicone gel, to form the sealing body 6 enables the surgical valveaccording to the invention to seal around two or more catheters insertedinto the axial passage 16. This is illustrated in FIG. 3, which shows across-section of the valve in the plane perpendicular to the axis withtwo catheters C1 and C2 inserted into the axial passage 16. When theouter surface 36 of the sealing body 6 compression of the sealing bodyforces part of the sealing body to fill the narrow cusp between the twocatheters, and achieves the desired seal.

FIGS. 4A through 4C show perspective views of the basic sealingmechanism of an adjustable surgical valve according to a second aspectof the invention. The adjustable surgical valve according to the secondaspect of the invention is similar to the adjustable surgical valveaccording to the first aspect of the invention, but the uniform radialcompression is applied to the sealing body in a different way.

The adjustable surgical valve according to the second aspect of theinvention is shown in its open (non-sealing) state in FIG. 4A. Theadjustable surgical valve 2 comprises a substantially cylindricalsealing body 7. The sealing body includes a substantially cylindricalaxial passage 12, through which one or more instruments, such as thecatheter C, can be passed.

The sealing body 7 is formed from the same type of elastomeric foammaterial or encapsulated silicone gel as the sealing body 6 (FIG. 1) ofthe first embodiment of the invention. As with the sealing body of thefirst embodiment of the invention, the sealing body 7, when subject to aradial compression, forms a fluid-tight seal with one or moreinstruments passed through the axial passage 12. Details of the materialof the sealing body 7 and of its sealing action are similar to those ofthe sealing body 6 (FIG. 1), and therefore will not be repeated.

The sealing body 7 preferably has a circular cross section in the planenormal to the axial passage. Unlike the sealing body of the firstembodiment of the invention, the area of the circular cross section ofthe sealing body 7 is substantially constant along the length of thesealing body.

The sealing body 7 occupies part of the bore of the braided sleeve 17.The braided sleeve may be attached to the surface of the sealing body 7with a suitable adhesive, or the sealing body may be molded inside thebraided sleeve, with the braided sleeve providing the outer surface ofthe braided sleeve/sealing body assembly, as shown in FIG. 4A.Alternatively, the braided sleeve 17A may be incorporated within thesealing body 7A, as shown in FIG. 4C.

In FIG. 4A, the braided sleeve 17 is a hollow cylinder with a circularcross section that, when elongated, exerts a uniform radial compression.Anything placed inside the braided sleeve, such as the sealing body 7,is subject to the uniform radial compression when the braided sleeve iselongated. Thus, the braided sleeve subjects the sealing body to auniform radial compression similar to that produced by the matingsurfaces of the first embodiment of the invention.

The braided sleeve 17 is preferably made of a loosely-woven fabric, suchas polyester, nylon, or polypropylene. To enable the braided sleeve togenerate a uniform radial compression when elongated, the warp threadsof the fabric are arranged at an angle relative to the longitudinal axisof the braided sleeve. Alternatively, the braided sleeve may be made ofa knitted material.

In FIG. 4A, the sealing body 7 occupies part of the length of thebraided sleeve 17. The braided sleeve is shown in its normal(non-elongated) state, and the sealing body 7 is not deformed. Aninstrument, such as the catheter C, placed in the axial passage 12 ofthe sealing body moves freely within the axial passage.

The effect of elongating the braided sleeve 17 on the sealing body 7 isillustrated in FIG. 4B, which shows the adjustable surgical valve 2 inits closed (sealing) state. Axially moving the part 27 of the braidedsleeve distal from the sealing body relative to the sealing body in thedirection shown by the arrow 32 elongates the braided sleeve and causesthe braided sleeve to exert a uniform radial compression on the sealingbody. The sealing body transmits the uniform radial compression exertedby the braided sleeve against its outer surface to the axial passage 12.The uniform radial compression deforms the axial passage, and causes itto seal with the catheter C. The magnitude of the radial compression isadjusted by changing the relative axial positions of the distal part 27of the braided sleeve and the sealing body.

As an alternative to axially moving the distal part 27 of the braidedsleeve relative to the fixed sealing body to elongate the braided sleeve17, the distal part 27 of the braided sleeve can be fixed, and thesealing body 7 can be moved axially in the direction opposite to thedirection indicated by the arrow 32. As a further alternative, both thesealing body and the distal part of the braided sleeve can be moved toelongate the braided sleeve.

Cross sections of a more complete embodiment of an adjustable surgicalvalve according to the second aspect of the invention are shown in FIGS.5A and 5B. The sealing body 7 of valve 52 is formed inside the proximalpart of the braided sleeve 17. The braided sleeve/sealing body assemblyis mounted in the bore of the cylindrical valve body 37. The proximalpart 22 of the braided sleeve/sealing body assembly is attached to thebore. The distal part 27 of the braided sleeve is attached to the innersurface 42 of the toroidal actuator 47.

The toroidal actuator 47 is free to slide axially within the bore of thevalve body 37. A mechanism (not shown), attached to the toroidalactuator, adjusts the axial position of the toroidal actuator in thebore, and hence the elongation of the braided sleeve 17. Mechanisms ofthe type to be discussed below, or some other suitable mechanism, can beused to adjust the axial position of the toroidal actuator in the boreof the valve body.

FIG. 5A shows the adjustable surgical valve 52 in its open (non-sealing)state. The braided sleeve 17 is shown in its normal (non-elongated)state, and the sealing body 7 is not deformed. An instrument, such asthe catheter C, placed in the axial passage 12 of the sealing body movesfreely within the axial passage.

FIG. 5B shows the adjustable surgical valve 52 in its closed (sealing)state. The mechanism (not shown) has moved the toroidal actuator 47 inthe bore of the valve body 37 in the direction of the arrow 57. Thiselongates the braided sleeve 17 and causes the braided sleeve to exert auniform radial compression on the sealing body 7. The sealing bodytransmits the uniform radial compression exerted by the braided sleeveagainst its outer surface to the axial passage 12, which deforms theaxial passage and causes it to seal with the catheter C. The magnitudeof the radial compression is adjusted by changing the axial position ofthe toroidal actuator 47 in the bore of the valve body 37.

Practical embodiments of an adjustable surgical valve according to theinvention employ both mating surfaces and elongation of a braided sleeveto apply a uniform radial compression to the axial passage in thesealing body.

FIG. 6 shows a perspective view of the first practical embodiment of anadjustable surgical valve 101 according to the invention. The introducersleeve S is attached to the distal end of the surgical valve 101, andpasses through an incision or puncture I into the body B. A catheter Cpasses through the valve 101 and the introducer sleeve S into the bodyB.

The valve body 100 of the surgical valve is a hollow, substantiallycylindrical plastic molding, preferably of polycarbonate. The bore ofthe valve body 100 has a circular cross section. A longitudinal slot 105is molded or cut in the valve body 100. The pillar 115 passes throughthe slot 105 and is attached to the toroidal body (see FIG. 7). The endof the pillar distal from the toroidal body is inserted and glued into asmall bore in the pawl 110. The pawl, which is preferably apolycarbonate molding, pivots by bending the pillar. The axis of thebore in the pawl is at an acute angle relative to the longitudinal axisof the pawl to bias the pawl into engagement with the ratchet 120.Alternatively, the pillar and pawl, or the pillar, pawl, and toroidalbody can be molded as an integral unit.

The pawl 110, pillar 115, and ratchet 120 provide the preferred way ofchanging the relative axial positions of the sealing body 106 and thetoroidal body 111 (FIG. 7) and of changing the elongation of the braidedsleeve 138 (FIG. 7). This mechanism has a small number of parts, can beadjusted precisely, and can be operated with one hand. Alternativemechanisms can be used to change the relative axial positions of thesealing body and the toroidal body, and the elongation of the braidedsleeve. For example, the twist mechanism to be described below inconnection with FIGS. 10, 11, and 12 can be adapted to this purpose.

Pressure applied radially to the protrusion 125 on the pawl 110disengages the pawl from the ratchet 120. The protrusion alsofacilitates axially sliding the pawl with the thumb to adjust the valve.The ratchet 120 is a metal stamping attached to the outer surface of thevalve body 100 by gluing, preferably with an epoxy adhesive.Alternatively, the ratchet can be molded as an integral part of thevalve body molding.

The flanged proximal and distal ends of the valve, 130 and 135,respectively, enable the valve to be gripped in the fingers of the handwhile adjusting the position of the pawl with the thumb. The flangedends are preferably integral parts of the valve body molding, but can beseparate polycarbonate moldings glued to the valve body 100 with acyanoacrylate or other suitable adhesive. The flanged end 135 mustmolded separately and later attached if the pawl, pillar and toroidalbody are molded as an integral unit.

FIG. 7 shows a longitudinal cross-sectional view of surgical valve shownin FIG. 6. The sealing body 106 and the toroidal body 111 are mounted inthe bore of the valve body 100. In the plane perpendicular to the axisdefined by the axial passage 116 ("the axis"), the sealing body has acircular cross section. The diameter of the sealing body, i.e., thedistance of the outer (mating) surface 136 of the sealing body from theaxis, is substantially constant along the length of the sealing body.The diameter of the sealing body is reduced near its distal end 126 toenable the sealing body to engage smoothly with the toroidal body.

The toroidal body 111 is a polycarbonate molding with inner and outercircular cross sections in the plane perpendicular to the axis. Itsouter diameter is slightly smaller than the diameter of the bore of thevalve body 100, and is substantially constant along its length. Thisenables the toroidal body to slide freely within the bore of the valvebody. The inner diameter of the toroidal body progressively decreasesfrom the proximal end 141 of the toroidal body to about half-way alongthe toroidal body, and remains substantially constant from abouthalf-way along the toroidal body to the distal end 146. If the pawl,pillar, and toroidal body are not molded as an integral unit, a smallradial bore is provided in the toroidal body to receive the pillar 115,which is glued in place with a suitable adhesive.

The sealing body 106 is formed by molding or extruding a suitablesilicone foam. The axial passage 116 is formed in the molding orextruding process. In the preferred embodiment, the sealing body ismolded using Type 762 silicone foam from General Electric. The outer(mating) surface 136 of the sealing body is provided by the braidedsleeve 138. The braided sleeve is a substantially cylindrical piece ofwoven polyester material that preferably is sealed with a siliconesealant, such as Type Q7-2213 sealant, manufactured by Dow Chemical Co.

The braided sleeve 138, after sealing, is placed in a mold and thesilicone foam is injected into the mold inside the braided sleeve. Whenthe completed sealing body/braided sleeve assembly is removed from themold, the braided sleeve is firmly attached to the foam of the sealingbody. Part of the braided sleeve forms the outer surface 136 of thesealing body. Alternatively, the foam can be molded separately and gluedin place inside the braided sleeve using a silicone RTV or othersuitable adhesive.

Using part of the sealed braided sleeve 138 for the outer (mating)surface 136 of the sealing body 106 provides a surface that is smootherand more durable than would be provided by the silicone foam alone. Thisprovides lower friction between the sealing body and the toroidal body111, which makes it easier to adjust the axial position of the toroidalbody, and enables the valve to be opened simply by releasing the pawl110.

The part of the braided sleeve 138 extending distally from the sealingbody 106 is called the sleeve extension 140. The sleeve extension passesthrough the bore of the toroidal body 111, and is attached to the valvebody 100 by trapping it between the large luer hub 145 and the distalend 135 of the valve body. The large luer hub is preferably glued intothe distal end of the valve body.

The braided sleeve 138 provides the sealing body 106 with tensilestrength and locates the sealing body axially so that the sealing bodycan withstand the axial force applied to it by the toroidal body 111.The braided sleeve also provides a uniform radial compression to on thesealing body. The axial force exerted by the toroidal body 111 as it isadvanced over the sealing body axially displaces the sealing body, andthus elongates the braided sleeve. The elongation of the braided sleeveprovides a radial compression to the sealing body in addition to theradial compression provided by the juxtaposition of the mating surfaces136 and 151 of the sealing body and the toroidal body, respectively.

The braided sleeve extension 140, being sealed with silicone sealant,provides a fluid-tight passage between the distal end 135 of the valvebody and the distal end 126 of the sealing body.

FIG. 7 shows the surgical valve according to the invention in its open(non-sealing) position. The proximal end 141 of the toroidal body isslightly engaged with the distal end 126 of the sealing body; but thediameter of the outer surface 136 of the sealing body at distal end 126is slightly reduced, so the toroidal body 111 does not deform thesealing body 106. Nor does the toroidal body 111 cause any elongation ofthe braided sleeve 138. Consequently, the axial passage 116 is notdeformed, and no seal is formed with the catheter C in the axialpassage.

FIG. 8 shows the surgical valve of FIG. 7 adjusted to form a minimumfriction-no leakage seal with the catheter C. This adjustment can becarried out using only one hand. The valve body 100 is gripped in thefingers, and the pawl 110 is pulled by the thumb in the directionindicated by the arrow 156. The axial position of the pawl, and hence ofthe toroidal body 111, is adjusted to provide a seal that does not leak,yet imposes minimum friction on the catheter, and hence resistance tothe movement of the catheter C. The low friction offered by the surgicalvalve according to the invention when adjusted in its minimumfriction-no leakage positions provides maximum tactile feedback to thesurgeon when inserting or adjusting an instrument, such as the catheterC, through the valve.

Moving the pawl 110 in the direction indicated by the arrow 156 movesthe toroidal body 111 in the same direction and engages the innersurface 151 of the toroidal body with the outer surface 136 of thesealing body. The inner surface 151 deforms the outer surface 136 of thesealing body, moving it radially towards the axis. In addition, theaxial movement of the toroidal body 111 moves the sealing body axially,which elongates the braided sleeve 138. The deformation of the outersurface 136 together with the elongation of the braided sleeve causesthe wall of the axial passage 116 to move uniformly towards, and to sealwith, the catheter C. The sealing body exerts an axial force on thetoroidal body 111 in the direction opposite to that indicated by thearrow 156, but the toroidal body is prevented from moving by the pawl111 engaged in the ratchet 120.

To release the valve completely, the valve body 100 is gripped in thefingers, and pressure is applied to the protrusion 125 with the thumb torelease the pawl 110 from the ratchet 120. The axial force exerted bythe sealing body 106 against the toroidal body 111 and the low frictionbetween the braided sleeve 138 on the outer surface 136 of the sealingbody and the inner surface 151 of the toroidal body makes the valveself-releasing. No axial pressure from the thumb is required to releasethe valve. To release the valve partially, the same procedure is used,except that the motion of the pawl is controlled, preferably by thethumb, and the pawl is re-engaged in the ratchet after the adjustmenthas been made.

FIG. 9 shows the surgical valve 101 according to the invention in itsfully closed position, i.e., with no catheter inserted into the axialpassage 116. The pawl 110, and hence the toroidal body 111, are movedfurther in the direction indicated by the arrow 156. This engages theinner surface 151 of the toroidal body still further with the outersurface 136 of the sealing body, and also increases the elongation ofthe braided sleeve 138. The increased radial deformation of the outersurface 136 of the sealing body further towards the axis and theincreased elongation of the braided sleeve together cause the wall ofthe axial passage 116 to move radially towards the axis, to seal withitself. The material of the sealing body 106 is sufficiently compliantto allow the wall of the axial passage to seal with itself undermoderate radial pressure. The pawl 110 and ratchet 120 hold the toroidalbody 111 in its set axial position until the pawl is released.

The additional adjustment of the axial position of the toroidal bodyshown in FIG. 9 is only necessary when a large-diameter catheter is tobe withdrawn from the surgical valve 101. In practice, when alarge-diameter catheter is to be withdrawn from the valve, the valve isleft set in the minimum friction-no leakage position shown in FIG. 8until the catheter is almost completely withdrawn. The position of thepawl 110, and hence of the toroidal body 111, is then adjusted towardsthe position shown in FIG. 9. This increases friction, but still allowsthe catheter to be withdrawn. When the catheter disengages from thecompressed part of the sealing body 106, the resilience of the sealingbody 106 causes the part of the axial passage 116 under compression fromthe toroidal body 111 and the braided sleeve 138 to collapse radiallytowards the axis, and seal with itself. Depending on the diameter of thecatheter C, the diameter of the sealing body 106, and the axial positionof the toroidal body when the catheter is withdrawn, the pawl 110, andhence the toroidal body 111, may have to be moved further in thedirection indicated by the arrow 156 to cut off residual leakage afterthe catheter has been withdrawn. With a smaller-diameter catheter, thevalve adjusted to the minimum friction-no leakage position shown in FIG.8 is self sealing, and no adjustment is necessary when the catheter iswithdrawn.

FIGS. 10 and 11 show a perspective view and a longitudinal crosssection, respectively, of a second practical embodiment of the surgicalvalve 201 according to the invention. In FIG. 10, the introducer sleeveS is sealed into the distal end of the surgical valve 201, and passesthrough an incision or puncture I in the body B. A catheter C passesthrough the valve 201 and the introducer sleeve S into the body B. Thevalve 201 has an outer valve body 202 and an inner valve body 207. Theouter valve body 202 and the inner valve body 207 together form thetoroidal body of the valve.

The outer valve body 202 is a hollow, substantially cylindricalpolycarbonate plastic molding. The bore of the outer valve body 202 hasa circular cross section, and is stepped towards the axis at itsproximal end to form the shoulder 212, which provides a first thrustbearing for the inner valve body 207, as shown in FIG. 11. The distalend 217 of the outer valve body provides a second thrust bearing for theinner valve body 207. The bore of the outer valve body flares outwardsproximally from the shoulder 212 to provide a first part of the innersurface 251A of the toroidal body of the valve. A longitudinal slot 218is molded or cut in the outer valve body 202.

The inner valve body 207 is a hollow, substantially cylindricalpolycarbonate plastic molding. The outer diameter of the inner valvebody 207 is slightly smaller than the diameter of the bore of the outervalve body 202 so that the inner valve body can rotate freely within theouter valve body. The bore of the inner valve body provides a secondpart 251B of the inner surface of the toroidal body of the valve. Aspiral slot 222, shown as a broken line in FIG. 10, is cut or molded inthe wall of the inner valve body 207.

The proximal end 227 of the inner valve body mates with the shoulder 212of the outer valve body to provide the first thrust bearing. The distalend of the inner valve body has a flange 232 that mates with the distalend 217 of the outer valve body to provide the second thrust bearing.Attached to the radially remote part of the flange 232 and coaxial withthe inner valve body 207 is the twist ring 237. The twist ring 237enables the inner valve body 207 to be gripped when the valve isadjusted.

A large luer hub 242 is attached to the distal end of the inner valvebody 207, preferably by gluing with a suitable adhesive. Alternatively,and preferably, the large luer hub 242 can be an integral part of theinner valve body molding. The sealing tube 247 passes through the bossof the large luer hub coaxial to the inner valve body. The sealing tubeis preferably an integral part of the inner valve body molding, but itcan be a separate tube of metal, for example, stainless steel, orplastic.

In the second practical embodiment of the invention, the collar 252longitudinally divides the sealing body 206 into a proximal part 206Aand a distal part 206B, and divides the axial passage 216 into aproximal part 216A, which is in the proximal part 206A of the sealingbody, and a distal part 216B. The proximal part 206A of the sealing bodyprovides the main sealing action of the valve. The outer surface of theproximal part 206A of the sealing body provides the outer surface 236 ofthe sealing body. The distal part 206B of the sealing body 206B providesthe required secondary seal between the static part of the valve, i.e.,the sealing tube 247, and the moving part of the valve, i.e., thesealing body 206.

The diameter of the distal part 216B of the axial passage is slightlysmaller than the outer diameter of the sealing tube 247, which allowsthe axial passage to form a fluid-tight seal with the sealing tube. Thediameter of the proximal part 216A of the axial passage is about thesame as the diameter of the bore of the sealing tube 247, and is thussmaller than the diameter of the distal part 216B of the axial passage.

In the plane perpendicular to the axis, the proximal part 206A of thesealing body has a circular cross section. Adjacent to the collar 252,the diameter of the proximal part 206A of the sealing body is slightlysmaller than the diameter of the bore of the inner valve body 207. Thediameter of the proximal part of the sealing body progressivelyincreases in the direction proximal to the collar 252. The rate ofincrease of diameter is similar to the rate of increase of diameter ofthe inner surface 251A of the outer valve body 202.

In the plane perpendicular to the axis, the distal part 206B of thesealing body has a circular cross section with a substantially constantdiameter. The outer diameter of the distal part of the sealing body isslightly smaller than the diameter of the bore of the inner valve body207, so that the distal part of the sealing body can freely slideaxially in the bore of the inner valve body.

The collar 252 is a plastic molding, preferably of polycarbonate. Theoutside diameter of the collar is slightly smaller than the diameter ofthe bore of the inner valve body 207, so that the collar can slidefreely in the bore of the inner valve body. The bore of the collar ispreferably larger than the outer diameter of the sealing tube 247. Aradial hole is drilled and tapped in the side of the collar to receivethe screw 257. The screw passes through the linear slot 218 in the outervalve body 202 and the spiral slot 222 in the inner valve body. A pinglued into the radial hole in the collar can be substituted for thescrew. Twisting the outer valve body relative to the inner valve body inthe direction shown by the arrow 262 (FIG. 10) moves the collar axiallyin the direction indicated by the arrow 256.

The sealing body 206 is formed by attaching a braided sleeve 240, whichis preferably a substantially cylindrical piece of woven polyestermaterial, to the bore of the collar 252, preferably by gluing with acyanoacrylate adhesive. The collar and braided sleeve are then placed ina mold, and a suitable elastomeric foam is injected radially on bothsides of the braided sleeve, and axially on both sides of the collar.Alternatively, the foam can be extruded around the braided sleeve andcollar. The axial passage 216 is formed in the molding or extrudingprocess. In the preferred embodiment, the sealing body is molded fromType 762 silicone foam manufactured by General Electric Co.Alternatively, the foam can be molded around the braided sleeve in amold that provides a waisted area to receive the collar. The collar canthen be attached to the exposed braided sleeve in the waisted area,preferably by gluing. The braided sleeve provides the elastomeric foamforming the sealing body with tensile strength, positively attaches thefoam of the sealing body to the collar, and, when elongated, radiallycompresses the sealing body.

In this second embodiment, the braided sleeve 240 does not form theouter surface of the sealing body 206, as it does in the firstembodiment. In the second embodiment, which lacks the pawl and ratchetarrangement of the first embodiment, some friction between the outersurface 236 of the sealing body and the inner surface 251A and 251B ofthe toroidal body is desirable to maintain the sealing body and thetoroidal body in their desired relative axial positions. Because of thisfriction, the valve is not self-releasing: the outer valve body 202 mustbe twisted relative to the inner valve body 207 in the directionopposite to that indicated by the arrow 262 to release the valve.Alternatively, the friction between the outer surface of the sealingbody and the inner surface of the toroidal body can be reduced, and thevalve provided with a rotational pawl and ratchet or similararrangement. Other mechanisms for changing the relative axial positionsof the sealing body and the toroidal body can also be used in the secondembodiment. For example, the linear pawl and ratchet arrangement of thefirst embodiment can be adapted for use in the second embodiment of thevalve.

FIG. 11 shows the surgical valve according to the invention in its open(non-sealing) position. The inner surface 251A of the toroidal bodylightly contacts the outer surface 236 of the sealing body such that theinner surface the toroidal body does not deform the outer surface ofsealing body. Moreover, the inner surface of the toroidal body appliesno axial stress to the sealing body, so there is no elongation of thebraided sleeve 240. Thus, the axial passage 216A is not deformed.

FIG. 12 shows the surgical valve of FIG. 11 adjusted to its fullysealing condition. The valve can be adjusted using only one hand. Thegripping ring 237 is gripped by wrapping the middle finger around it andthe proximal end of the outer valve body 202 is gripped between thethumb and forefinger. To seal the valve, the thumb and forefinger aremoved relative to the middle finger to twist the outer valve body 202 inthe direction indicated by the arrow 262. This causes the collar 252,and hence the sealing body 206, to move in the direction indicated bythe arrow 256.

The collar 252 moving in the direction indicated by the arrow 256 drawsthe outer surface 236 of the sealing body into engagement with the innersurface 251A and 251B of the toroidal body. The rigid inner surface 251Aand 251B of the toroidal body deforms the outer surface 236 of thesealing body moving it radially towards the axis. In addition, thetoroidal body applies an axial stress to the sealing body, whichelongates the braided sleeve 240. The deformation of the outer surfaceof the sealing body and the elongation of the braided sleeve togethercause the wall of the axial passage 216A to move towards the axis, and,when the sealing body has been drawn far enough into the toroidal body,to seal with itself.

Drawing the sealing body further into the toroidal body increases thedeformation of the outer surface of the sealing body and the elongationof the braided sleeve. This increases the length of the sealed part ofthe axial passage 216A and the inward radial pressure on the wall of theaxial passage.

Like the first practical embodiment, the second practical embodiment ofthe surgical valve according to the invention can be adjusted to providea "minimum friction-no leakage" seal around one or more catheters. Also,like the first practical embodiment, the second practical embodiment isself sealing from the minimum friction-no leakage position with asmaller-diameter catheter, and from a higher friction position with alarger-diameter catheter. The second practical embodiment of the valvecan provide manual sealing of the valve, which the first practicalembodiment cannot provide. When the second practical embodiment of thevalve is in its open (non-sealing) position, the proximal end of thesealing body 206 projects proximally from the proximal end of the outervalve body 202, as shown in FIG. 11. The exposed part of the sealingbody can therefore be gripped by an opposed thumb and finger, or byforceps, to provide manual sealing.

What is claimed is:
 1. A surgical valve, comprising:a sealing body having a smooth axial passage extending therethrough, the axial passage defining an axis, the sealing body having an axial position on the axis; a toroidal body, axially aligned with the sealing body, and having an axial position on the axis, the sealing body and the toroidal body including mating surface means having a substantially circular cross section whereby changing the axial position of one of the sealing body and the toroidal body relative to the other creates a circumferentially uniform radial force to compress the axial passage of the sealing body; and a position changing means for selectively changing the axial position of one of the sealing body and the toroidal body relative to the other.
 2. The surgical valve of claim 1, wherein the position changing means moves the toroidal body axially relative to the sealing body.
 3. The surgical valve of claim 1, wherein:the mating surface means of the sealing body is of a cross section that increases along the axis from a minimum to a maximum; and the mating surface means of the toroidal body is of a substantially constant cross section that is less than the maximum cross section of the mating surface means of the sealing body.
 4. The surgical valve of claim 3, wherein:the mating surface means of the sealing body is of a substantially circular cross section; and the mating surface means of the toroidal body is of a substantially circular cross section.
 5. The surgical valve of claim 1, wherein:the mating surface means of the sealing body is of a cross section that increases along the axis from a minimum to a maximum; and the mating surface means of the toroidal body is of a cross section that increases along the axis from a minimum to a maximum in the same direction as the direction in which the cross section of the mating surface means of the sealing body increases.
 6. The surgical valve of claim 1, wherein:the mating surface means of the toroidal body is of a cross section that increases along the axis from a minimum to a maximum; and the mating surface means of the sealing body is of a substantially constant cross section that is greater than the minimum cross section of the mating surface means of the toroidal body.
 7. The surgical valve of claim 1, whereinthe sealing body includes a braided sleeve disposed coaxially with the axial passage; and the position changing means is additionally for axially elongating the braided sleeve, the axial elongation causing the braided sleeve to contract radially.
 8. The surgical valve of claim 1, wherein the position changing means includes a pawl and ratchet.
 9. The surgical valve of claim 1, wherein the position changing means includes a means for translating rotational motion about the axis into longitudinal motion along the axis.
 10. The surgical valve of claim 1, wherein the sealing body comprises an elastomeric foam.
 11. The surgical valve of claim 1, wherein the sealing body comprises an encapsulated gel.
 12. A surgical valve comprising:a substantially cylindrical valve body having a bore; a sealing body fixed coaxially in the bore of the valve body, the sealing body having an axial passage extending therethrough; a toroidal body, axially aligned with the sealing body, slidably mounted in the bore of the valve body, and having an axial position therein, the sealing body and the toroidal body having mating surface means whereby changing the axial position of the toroidal body compresses the axial passage of the sealing body; and means attached to the toroidal body for selectively changing the axial position of the toroidal body.
 13. The surgical valve of claim 12, wherein:the mating surface means of the toroidal body is of a circular cross section; the cross section of the mating surface means of the toroidal body decreases along the axis in the direction away from the sealing body; the mating surface means of the sealing body is of a circular cross section; and the cross section of the mating surface means of the sealing body is substantially constant along the axis.
 14. The surgical valve of claim 12, wherein:the sealing body includes a braided sleeve coaxial with the axial passage; the braided sleeve extends from the sealing body to provide a remote part; and the remote part of the braided sleeve is attached to the valve body.
 15. The surgical valve of claim 14, wherein the braided sleeve provides a sealed passage between the valve body and the sealing body.
 16. The surgical valve of claim 14, wherein the means for selectively changing the axial position of the toroidal body is additionally for axially elongating the braided sleeve to contract the braided sleeve radially.
 17. The surgical valve of claim 12, wherein:the valve body has an outer surface and includes a longitudinal slot; and the means for selectively changing the axial position of the toroidal body includes:a ratchet attached to the outer surface of the valve body, and a pawl attached to the toroidal body, passing through the longitudinal slot, and engaging with the ratchet.
 18. The surgical valve of claim 12, wherein the sealing body comprises an elastomeric foam.
 19. The surgical valve of claim 12, wherein the sealing body comprises an encapsulated gel.
 20. A surgical valve comprising:a sealing body, the sealing body:having an axial passage extending therethrough, the axial passage defining an axis, the sealing body having a position on the axis, and including a braided sleeve coaxial with the axial passage, the braided sleeve extending from the sealing body to provide a remote part, the remote part having a position on the axis; and a position changing means for selectively changing the position of one of the sealing body and the remote part of the braided sleeve relative to the other to elongate the braided sleeve axially, thereby radially compressing the axial passage of the sealing body.
 21. The surgical valve of claim 20, wherein the position changing means includes a toroidal body attached to the remote part of the braided sleeve.
 22. The surgical valve of claim 21, wherein:the sealing body has an outer surface; the braided sleeve has an inner surface and an outer surface; the toroidal body has an inner surface; the sealing body is mounted within the braided sleeve with the outer surface of the sealing body attached to the inner surface of the braided sleeve; and the outer surface of the braided sleeve is attached to the inner surface of the toroidal body.
 23. The surgical valve of claim 21, wherein:the surgical valve additionally comprises a cylindrical valve body having a bore; the sealing body is attached to the bore of the valve body; and the toroidal body is slidably mounted within the bore of the valve body.
 24. The surgical valve of claim 20, wherein:the surgical valve additionally comprises a cylindrical valve body having a bore; the sealing body is slidably mounted within the bore of the valve body; and the remote part of the braided sleeve is attached to the bore of the valve body.
 25. The surgical valve of claim 20, wherein the braided sleeve is made of a knitted material.
 26. The surgical valve of claim 20, wherein the braided sleeve is made of a woven material, the woven material having a warp that is angularly offset relative to the axis.
 27. The surgical valve of claim 20, wherein the sealing body comprises an elastomeric foam.
 28. The surgical valve of claim 20, wherein the sealing body comprises an encapsulated gel. 